Clinical trials: Pressure Injuries
Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs)
Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting.
- Conditions
- Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers, Surgical Wound Dehiscence (SWD)
- Trial name
- NCT06939673
- Testing
- Acellular Porcine-Derived Wound Matrix
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Reprise Biomedical, Inc.
Impaired Wound Healing
A Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Complete Closure of Wagner Grade 1-4 Diabetic Foot Ulcers, Venous Leg Ulcers and Stage II-IV Pressure Ulcers
This study is designed to demonstrate the outcome of complete ulcer closure of patients with Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary Care (UCC).
- Trial name
- NCT02248077
- Testing
- AutoloGel, Usual and Customary Care (UCC)
- Sponsor
- Cytomedix
Skin Lesion, Traumatic Ulcer
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
The aim of this clinical investigation is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three wound area measurement methods: Ruler using the Kundin method…
- Conditions
- Skin Lesion, Traumatic Ulcer, Hematoma, Pressure Ulcer
- Trial name
- NCT05729334
- Testing
- Clinicgram Euclides
- Where
- Spain
- Volunteers
- 65 people
- Sponsor
- Skilled Skin S.L.
Chronic Wounds, Venous Leg Ulcer (VLU)
Evaluation of Cold Plasma in Chronic Wound Healing
The goal of this clinical trial is to evaluate the effectiveness of cold atmospheric plasma treatment in promoting the healing of chronic wounds in adult participants suffering from chronic wounds.
- Conditions
- Chronic Wounds, Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
- Trial name
- PLASANAGENESIS (NCT06964048)
- Testing
- Cold Atmospheric Plasma treatment
- Volunteers
- 66 people
- Sponsor
- Plasana Medical
Pressure Ulcers
HP011-101, HP828-101, and Standard Care for Pressure Ulcers
Testing a drug and a device for the treatment of pressure ulcers, compared with current treatments.
- Trial name
- NCT01273428
- Testing
- HP011-101, HP-828-101, Standard Care
- Sponsor
- Healthpoint
Surgical Wound, Bilateral Total Knee Arthroplasty
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.
- Conditions
- Surgical Wound, Bilateral Total Knee Arthroplasty, Wounds and Injuries, Joint Diseases
- Trial name
- ENABLE (NCT04712019)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard Silver-containing Dressing
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Solventum US LLC
Compartment Syndrome
Study of New Catheter & Pressure Monitor System to Help Prevent Compartment Syndrome From Developing in the Injured Leg
An investigation of a new catheter and pressure monitor system that may help to prevent a complication called compartment syndrome from developing in an injured leg.
- Trial name
- TS2 (NCT00681616)
- Testing
- Compartment Monitoring System (CMS), Compartment Monitoring System with Active Fluid Removal, Compartment Monitoring System without fluid removal
- Where
- 13 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Twin Star Medical, Inc.
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Skin Ulcer, Pressure Ulcer (PU)
Study Title: A Multicenter, Prospective, Modified Platform Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers.
A multicenter prospective modified platform trial evaluating several cellular, acellular, and matrix like products and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.
- Conditions
- Skin Ulcer, Pressure Ulcer (PU), Pressure Ulcer of Skin, Pressure Sore
- Trial name
- RESTORE (NCT07665268)
- Testing
- Activate™ Matrix + SOC, AmnioDefend™ FT Matrix + SOC, Palisade™ DM Matrix + SOC
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Sequence LifeScience, Inc.
Burn Wound, Pressure Ulcers Stage II
Study to Evaluate the Performance and Safety of the Medical Device Argogen
A wound, i.e., a break in the skin, can result from several reasons. Pressure ulcers (also called pressure sores, bed sores and decubitus ulcers) are localized damage to the skin and underlying soft tissue usually over a bony…
- Conditions
- Burn Wound, Pressure Ulcers Stage II, Pressure Ulcers Stage III
- Trial name
- NCT05649332
- Testing
- Argogen (silver zeolite powder)
- Where
- 2 sites in Romania
- Volunteers
- 58 people
- Sponsor
- Signorini Medicale S.r.l.
Wound Heal
Performance, Safety and Efficacy of PICO Device.
The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the…
- Trial name
- NCT03698968
- Testing
- Negative Pressure Wound Therapy
- Where
- 11 sites in Switzerland, United Kingdom
- Volunteers
- 50 people
- Sponsor
- Smith & Nephew, Inc.
Soft Tissue Defects, Soft Tissue Wounds
Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
- Conditions
- Soft Tissue Defects, Soft Tissue Wounds, Traumatic Soft Tissue Defect
- Trial name
- COVER (NCT07385313)
- Testing
- Myriad™ applied in conjunction with NPWT, NPWT Alone
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Aroa Biosurgery Limited
Bronchopulmonary Dysplasia
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5…
- Trial name
- NCT00931632
- Testing
- Inhaled Nitric Oxide
- Where
- 33 sites in United States, Canada
- Volunteers
- 451 people
- Sponsor
- Mallinckrodt
Pressure Ulcers Stage III, Pressure Ulcer, Stage IV
Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure Injuries
The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 \& 4 pressure ulcers using ACell products.
- Conditions
- Pressure Ulcers Stage III, Pressure Ulcer, Stage IV, Pressure Ulcer
- Trial name
- NCT03283787
- Testing
- MicroMatrix® and Cytal™ Wound Matrix 2-Layer, MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT, Negative Pressure Wound Therapy
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Integra LifeSciences Corporation
Wound Healing and Prevention
Performance, Safety and Efficacy of NPWT Device
Smith \& Nephew are assessing a new investigational single use NPWT system.
- Trial name
- NCT04102865
- Testing
- Negative-Pressure Wound Therapy (NPWT)
- Where
- 8 sites in United Kingdom
- Volunteers
- 90 people
- Sponsor
- Smith & Nephew, Inc.
Pressure Ulcer
Effectiveness of Aurix Therapy in Pressure Ulcers
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard care and compared 1:1 to…
- Trial name
- NCT02352467
- Testing
- Aurix
- Where
- 22 sites in United States
- Volunteers
- 800 people
- Sponsor
- Nuo Therapeutics
Wounds
The Use of CureXcellTM in a Community Setting for the Treatment of Hard to Heal Wounds
The primary objective of the study is to define procedures for the use of CureXcellTM in the community through Clalit Health Services.
- Trial name
- NCT01113307
- Testing
- Activated allogeneic white blood cells
- Where
- 7 sites in Israel
- Volunteers
- 131 people
- Sponsor
- Macrocure Ltd.
Head Injury
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial…
- Trial name
- NCT01824589
- Testing
- -7 cm H2O ITPR, -12cm H2O ITPR
- Volunteers
- 1 people
- Sponsor
- Advanced Circulatory Systems
Pressure Ulcer, Venous Ulcer
PuraPly™ Antimicrobial Wound Matrix and Wound Management
The PuraPly Antimicrobial Wound Matrix (PuraPly AM) case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylenbiguanide…
- Conditions
- Pressure Ulcer, Venous Ulcer, Diabetic Ulcer, Surgical Wound
- Trial name
- PuraPlyAM (NCT03070938)
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Organogenesis
Lower Extremity, Chronic Ulcers
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
To prospectively evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic lower extremity wounds.
- Conditions
- Lower Extremity, Chronic Ulcers, Pressure Ulcer (PU), Venous Leg Ulcer (VLU)
- Trial name
- NCT07862335
- Testing
- PRFM
- Volunteers
- 30 people
- Sponsor
- Tiger Biosciences, LLC.